CHESTERBROOK, PA — Trevena, Inc. (Nasdaq: TRVN) announced the recent completion of the initial analysis of OLINVYK continuous respiratory monitoring data from the VOLITION study.
The VOLITION study, a real-world, open-label, multi-site study, assessed the potential impact of OLINVYK on respiratory, gastrointestinal (GI), and cognitive function outcomes in the postoperative setting. The Company previously announced GI and cognition data from the study.
“We are pleased to announce completion of the initial analysis of respiratory data from the ~200 patient VOLITION study generated at Cleveland Clinic and Wake Forest Baptist Health,“ said Carrie Bourdow, President and CEO of Trevena. “We are excited to present these new results at the upcoming ASA meeting in October.”
- VOLITION Study Data, Including Continuous Respiratory Monitoring Analysis, to be Presented at ASA in San Francisco from October 13-17, 2023. The Company has three abstracts accepted for presentation at ASA, which will be held in San Francisco from October 13-17. One abstract was selected for an oral presentation as a top research abstract. The oral presentation titled “Antinociception versus Neurocognitive Effect of Biased mu-Opioid Receptor Oliceridine versus Morphine: Utility Function Analyses” will be part of the Best of Abstracts: Clinical Science feature session. The abstracts are embargoed until the conclusion of the meeting and at which time they will be available at https://www.trevena.com/publications.
- Company to Participate in the BIO Investor Forum in San Francisco from October 17-18, 2023. Members of the Trevena management team will be participating in 1×1 meetings and encourage investors to schedule a time during the conference.
VOLITION Study Details
VOLITION is a real-world, open-label, multi-site, post-approval clinical outcomes study in 203 adult patients undergoing major non-cardiac surgery (197 patients with evaluable respiratory data). IV OLINVYK was dosed as the first-line analgesic during post-operative care, with a 1.5mg loading dose of OLINVYK at surgical closure, and 0.35mg to 0.5mg of OLINVYK, as needed, administered with a PCA device, with a 6-minute lockout period. Additional boluses (≤1 mg) of OLINVYK were available if needed as soon as 15 minutes after the initial 1.5 mg loading dose.
Patients in the VOLITION study wore a device that continuously monitored physiologic status including heart rate, respiratory rate and indices of oxygen and expired carbon dioxide, with data from this monitoring collected in a manner blinded to the clinical staff caring for the patient. The continuous monitoring methods used in the VOLITION study were modeled after the similar methodology of respiratory depression assessment used in the recently completed PRODIGY study, which itself was led by clinical outcomes research experts from Wake Forest Baptist Health and the Cleveland Clinic. As in the PRODIGY study, investigators in the VOLITION study evaluated the proportion of patients meeting an expert adjudicated criterion of meaningful respiratory compromise, defined by a collapsed composite of any one or more of: 1) end-tidal carbon dioxide <15mmHg for ≥3 minutes; 2) respiratory rate ≤5 breaths/minute for ≥3 minutes; 3) SpO2 ≤ 85% for ≥3 minutes; 4) Apnea episode lasting >30 seconds; 5) any serious respiratory event. No drug-related serious adverse events (SAEs) and no deaths were reported in the VOLITION study.
The average age of patients in VOLITION was 57.1 years (range 19 to 89), with approximately equal representation of men and women. Approximately 86% of patients underwent an abdominal surgical intervention, such as partial or total colectomy, enterotomy or other open abdominal procedures. A majority of patients had significant morbidity at the time of surgery as reflected by ASA status, and their respiratory risk was intermediate to high risk, graded using the PRODIGY risk score. The average duration of the surgery was 4.8 hours (range of 1.2 to 12.6 hours).
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